Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation (RESPIRA-02)

Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation in Stable Phase and in Weaning Phase

The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: RESPIRA device.com® Advanced

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Beltran Argudo; Phone Number: +34627988922; Email: dbeltran@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
    • Contact: Daniel Beltran Argudo; Phone Number: +34627988922; Email: dbeltran@clinic.cat
  • Barcelona, Spain, 08024
    • Clínica Nostra Senyora del Remei
    • Contact: Daniel Beltran Argudo; Phone Number: +34627988922; Email: dbeltran@clinic.cat
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias y Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age equal to or greater than 18 years
• Availability of a family member or legal representative capable of understanding and signing the informed consent
• Patient admitted to the intensive care unit requiring invasive mechanical ventilation, who shows:
• Hemodynamic stability: MAP ≥ 65 mmHg and norepinephrine requirements ≤ 0.5 µg / kg / min, and
• Respiratory stability: PaO2 / Fraction of Inspired Oxygen (FiO2)> 100 and stable oxygen requirements in the previous 6 hours.
• In case is considered to start phase of "weaning" or awakening, the level of sedation should allow adequate triggering of the inspiratory trigger, in a patient with improvement of respiratory failure and / or radiological image.

Exclusion Criteria:

• Age under 18 years
• Weight less than 50 kg
• Body weight greater than 120 kg
• Height greater than 1,90 m
• Presence of barotrauma (pneumothorax) or pleural fistula
• Hemodynamic instability (MAP < 65 mmHg or norepinephrine requirements > 0,5 µg /kg / min)
• Neurocritical patient
• Obstetric patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients undergoing mechanical ventilation in stable phase; 15 Patients will be changed from a basal reference ventilator to the RESPIRA ADVANCED device. The patient will be ventilated for the next 24 hours with the investigational medical device or until one withdrawal criteria is met according to clinical investigation plan. After 24 hours of ventilation with the investigational medical device, the patient will be changed to the previous conventional ventilation device.	Device: RESPIRA device.com® Advanced; Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.
EXPERIMENTAL: Patients undergoing mechanical ventilation in weaning phase; 15 Patients will be changed from a basal reference ventilator to the RESPIRA ADVANCED device. The patient will be ventilated for the next 24 hours with the investigational medical device or until one withdrawal criteria is met according to clinical investigation plan. After 24 hours of ventilation with the investigational medical device, the patient will be changed to the previous conventional ventilation device.	Device: RESPIRA device.com® Advanced; Ventilation of patients with continuous monitoring of the patient's clinical parameters and the parameters that the investigational medical device shows.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes in PaO2 during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the failure of the device	Amount of patients that required the use of the conventional ventilator due to a therapeutic failure of the investigational device	This variable will be analyzed at the end of the study (36 hours)
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the tidal volume of the device	Evolution of the tidal volume during the ventilation of the patient in hours	This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the peak pressure of the device	Evolution of the peak pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the plateau pressure of the device	Evolution of the plateau pressure during the ventilation of the patient in hours	This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 0.33 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 0.66 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 2 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 4 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 12 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 20 hours
Evaluate the reliability and temporal consistency of the breathing rate of the device	Evolution of the breathing rate during the ventilation of the patient in hours	This variable will be measured and recorded at 24 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm	Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours	This variable will be measured and recorded at 8 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm	Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours	This variable will be measured and recorded at 16 hours
Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm	Evolution of the inspiration-expiration ratio during the ventilation of the patient in hours	This variable will be measured and recorded at 24 hours
Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes of pH during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)
Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes of PaCO2 during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)
Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes of oxygen saturation during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)
Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes of heart rate during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)
Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation	Significant changes of breathing during the ventilation of the patient	This variable will be analyzed at the end of the study (36 hours)
Safety Assessment	Number of device related serious and unexpected adverse events reported during the use of the device	This variable will be analyzed at the end of the study (36 hours)
Protective Measures Assessment	Number of alarms activated by the investigational device during the ventilation procedure	This variable will be analyzed at the end of the study (36 hours)

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: Josep María Nicolás Arfelis, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (ACTUAL): December 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: RESPIRA-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No